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Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

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ClinicalTrials.gov Identifier: NCT03612570
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pulse Biosciences, Inc.

Brief Summary:
This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

Condition or disease Intervention/treatment Phase
Skin Lesion Skin Abnormalities Sebaceous Hyperplasia Device: Nano-Pulse Stimulation Device Not Applicable

Detailed Description:
The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. One lesion will be randomized as a untreated control and no NPS energy will be delivered. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : December 20, 2018

Arm Intervention/treatment
Experimental: NPS Treated SH Lesion
Nano-Pulse Stimulation Device using pre-defined energy protocol
Device: Nano-Pulse Stimulation Device
NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.




Primary Outcome Measures :
  1. Lesion Clearance [ Time Frame: 60-day Follow-up ]
    At least 50% of the NPS treated lesions will be rated as "CLEAR" or "MOSTLY CLEAR"



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females
  • Presents with at least 2 and up to 5 clinically visible SH lesions
  • Understands that 1 lesion will remain untreated to act as a reference
  • Lesions must measure no greater than 2.5 x 2.5 at the outside margin
  • Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion
  • Selection of the non-treated reference lesion will be randomly identified
  • Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days
  • Agrees to photographic or other image capture methods of both the treated and untreated lesions.
  • Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study
  • Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days
  • Is not allergic to Lidocaine or Lidocaine-like products

Exclusion Criteria:

  • Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator
  • Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device
  • SH lesions are located within the eye orbit or on the nose
  • Active infection or history of infection in designated test area within 90 days prior to study initiation
  • Use of oral steroid and/or retinoid use within the last 12 months
  • Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start
  • Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start
  • Taking blood thinning medications
  • Has Insulin dependent diabetes
  • Is known to be pregnant or lactating female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612570


Locations
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United States, California
Laser & Skin Surgery Medical Group, Inc.
Sacramento, California, United States, 95816
Premier Plastic Surgery
San Mateo, California, United States, 94401
United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Zel Skin & Laser Specialists
Edina, Minnesota, United States, 55424
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Pulse Biosciences, Inc.
Investigators
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Study Chair: Richard Nuccitelli, PhD Pulse Biosciences, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pulse Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03612570    
Other Study ID Numbers: NP-SH-006
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pulse Biosciences, Inc.:
Nano-Pulse Stimulation
NPS
Additional relevant MeSH terms:
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Skin Abnormalities
Hyperplasia
Congenital Abnormalities
Pathologic Processes
Skin Diseases